JAI
- Product code
- JAI
- Device name
- Couch, Radiation Therapy, Powered
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.5770
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 32 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K231612 | 2024-05-07 | Leo Cancer Care | Eve Patient Positioner System |
Official FDA classification page: JAI
Classification and pathway per current FDA publications. Data from openFDA (CC0).